HuCog Special Precautions

hCG should be given with care to patients in whom fluid retention might be a hazard, as in asthma, epilepsy, migraine or cardiac or renal disorders. hCG preparations should only be used under the supervision of a specialist having available adequate facilities for appropriate laboratory monitoring.
In the female: Use in induction of ovulation may result in ovarian enlargement or cysts, acute abdominal pain, superovulation or multiple pregnancies, particularly if endocrine monitoring is inadequate. Since infertile women undergoing assisted reproduction, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early ultrasound confirmation that a pregnancy is intrauterine is therefore important. Rates of pregnancy loss in women undergoing assisted reproductive technologies (ART) are higher than in the normal population. Prior to treating patients for inadequate endogenous stimulation of the gonads, an examination should be performed to exclude anatomical abnormalities of the genital organs or nongonadal endocrinopathies (e.g., thyroid or adrenal disorders, diabetes). Primary ovarian failure should be excluded by the determination of gonadotrophin levels. Unwanted hyperstimulation: During treatment of female patients, determinations of oestrogen levels and assessment of ovarian size and if possible, ultrasonography should be performed prior to treatment and at regular intervals during treatment. High dosages may cause oestrogen levels to rise excessively rapidly, e.g., more than doubling on 2 or 3 consecutive days, and possibly reaching excessively high pre-ovulatory values. The diagnosis of unwanted ovarian hyper stimulation may be confirmed by ultrasound examination. If unwanted hyperstimulation occurs (i.e., not as part of a treatment preparing for IVF/ET or GIFT or other assisted reproduction techniques), the administration of HMG should be discontinued immediately. hCG must not be given, because the administration of an hLH active gonadotrophin at this stage may induce, in addition to multiple ovulations, the ovarian hyperstimulation syndrome. This warning is particularly important with respect to patients with polycystic ovarian disease. The severe form of ovarian hyperstimulation syndrome may be life-threatening and is characterized by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, very often hydrothorax and occasionally thrombo-embolic phenomena.
Women with generally recognised risk factors for thrombosis, such as a personal or family history, severe obesity (Body Mass Index >30 kg/m2) or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotrophins. In these women the benefits of IVF treatment need to be weighed against the risks. It should be noted, however, that pregnancy itself also carries an increased risk of thrombosis. There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for infertility treatment. It is not yet established whether or not treatment with gonadotrophins increases the baseline risk of these tumours in infertile women. HuCoG should not be used for body weight reduction. HCG has no effect on fat metabolism, fat distribution or appetite.
In the male: Treatment with hCG leads to increased androgen production. Therefore: Patients with latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions) should be kept under close medical supervision, since aggravation or recurrence may occasionally be induced as a result of increased androgen production. hCG should be used cautiously in prepubertal boys to avoid premature epiphyseal closure or precocious sexual development. Skeletal maturation should be monitored regularly.